Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.
Recall
- Recall Number
- Z-0033-2012
- Event Number
- 59879
- Firm
- Isopure Corp
- FEI Number
- 3013942511
- Product Code
- FJP
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 19, 2011
- Posted
- October 11, 2011
- Terminated
- February 19, 2013
- Address
- 141 Citizens Blvd, Simpsonville, KY, 40067-6548
Description
Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.
Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.
Isopure sent a letter dated May 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Isopure devised an immediate solution which must be implemented at their faclity in conjunction with the disinfection procedure. Customers were asked to inform all appropriate personnel, clinical and technical, who may be involved in operating the system during the normal disinfection schedule. On 5/19/2011, the firm sent letters to their customers via US mail and email. They also telephoned their customers to notify them of the problem.
Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.
11 units